Easy13485 Makerspace · MedTech startups & SMEs

Build the product. Keep the path clear.

A QMS-/Regulatory Operating Model that helps teams clarify the claim, choose a plausible route and build evidence without turning early product work into regulatory debt.

Before the Journey

The Journey turns uncertainty into a path.

Once the Makerspace gives the operating model, the Journey shows how a team moves through it: from claim clarity to planning, evidence, automation and operated QMS practice.

Enter the Journey

Easy13485 Journey

Stage 01 / 05

Claim Check

First, know what you are.

Easy13485 Journey

Stage 02 / 05

Explore & Plan

Plan the route before regulatory debt starts.

What it is

Explore the
five
capabilities

The Easy13485 Makerspace wraps structure, tools, knowledge, evidence logic and training around the way MedTech teams actually work.

Your team keeps building the product. The Makerspace makes the regulatory path visible and helps the necessary QMS structure grow underneath.

The system is carried by five capabilities: evidence, guided expertise, role training, QMS operation and readiness support.

01

Evidence & Technical Documentation

Turns product decisions, risk logic, verification and reviews into structured evidence and usable technical documentation.

 02

Easy Expert

Helps the team find the right process, role, template, task or evidence logic inside the Easy13485 framework.

 03

Academy & Role Training

Builds role clarity, training evidence and practical QMS understanding without stopping product work.

 04

QMSaaS

Provides the maintained operating environment for roles, processes, records and daily QMS routines.

 05

Readiness Audit & Audit Support

Makes gaps visible and supports audit-oriented preparation before external pressure starts.

Next right step

Start with the Claim Check.

The Claim Check shows where the team stands, which route is plausible and which product line fits. No full QMS commitment before the claim is understood.

Request Claim Check Fellowship Review

Fellowship Program

Curated Makerspace access for serious early-stage MedTech teams.

Fellowship is for startups with strong product potential and the discipline to build regulatory structure early — before documentation debt, unclear roles or late audit pressure slow the team down.

It is not a discount tier. It is a reviewed entry path with a defined scope, clear expectations and access to the Makerspace where it can create real progress.

Apply for Fellowship Review Review the Journey
01

Product potential

A serious MedTech direction with a plausible route toward market.

02

Team readiness

A team willing to work with roles, evidence and review logic early.

03

Makerspace fit

A scope where guided structure helps the product move without overbuilding.

Easy13485 Journey

Stage 01 / 05

Claim Check

First, know what you are.

Contact us
You Decide

Start smart. Choose how you want to begin.

For startups, we offer a simple entry into professional compliance and quality management.

Start your Medtech Journey

Build the right foundation and get rewarded.

  • “16 Obligations of a Manufacturer” course
  • Certificate after completion
  • First consulting call included – free
  • Assessment for Claim Check
Start the free E-learning

Direct Consulting

Start immediately with tailored expert support.

  • First consulting hour: 162€
  • No prerequisites
  • Startup-focused, practical guidance
Book a Consulting Call (162€)
ipp.

Contact

  • Kerschensteinerstr. 79
    90471 Nürnberg
  • kontakt(at)ipp-nbg.com

Office hours

Monday to Friday
8:00 am - 2:00 pm